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| ID | Type | Description | Link |
|---|---|---|---|
| 212082PCR1005 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the effect of timing of food intake on systemic abiraterone exposure observed in healthy adult Japanese and Caucasian men.
This is a randomized (individuals will be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), single dose, 4-way crossover study of abiraterone acetate in approximately 48 healthy adult Japanese and Caucasian men. For the crossover design, the treatment sequences are defined as follows: 1 - ADBC, 2 - BACD, 3 - CBDA, and 4 - DCAB; where Treatment A = abiraterone acetate administered in the fasted state, Treatment B = standardized meal administered 1 hour after abiraterone acetate dose, Treatment C = standardized meal administered 2 hours after abiraterone acetate dose, and Treatment D = standardized meal administered 2 hours before and 2 hours after abiraterone acetate dose. This study will consist of a screening period followed by four open-label treatment periods separated by a washout period of at least 14 days between dosing. Eligible participants will be randomly assigned on Day 1 to 1 of 4 treatment sequences that differ with regard to timing of food intake before and/or after dosing with a single dose of 1000 mg of abiraterone acetate. Serial pharmacokinetic (study of what the body does to a drug) samples will be collected during the open-label treatment phase as detailed in the protocol. Safety will be monitored throughout the study. End-of-study assessments will be performed on Day 4 of Period 4 or upon early withdrawal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental |
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| Treatment B | Experimental |
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| Treatment C | Experimental |
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| Treatment D | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone: Treatment A | Drug | 1000 mg abiraterone acetate administered in the fasting state |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in mean plasma concentrations of abiraterone | Up to Day 4, treatment period 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean plasma concentrations of abiraterone | Up to Day 4, treatment period 4 | |
| Maximum plasma concentration of abiraterone | Up to Day 4, treatment period 4 | |
| Time to reach the maximum plasma concentration of abiraterone |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cypress | California | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25344090 | Derived | Inoue K, Shishido A, Vaccaro N, Jiao J, Stieltjes H, Bernard A, Yu M, Chien C. Pharmacokinetics of abiraterone in healthy Japanese men: dose-proportionality and effect of food timing. Cancer Chemother Pharmacol. 2015 Jan;75(1):49-58. doi: 10.1007/s00280-014-2616-4. Epub 2014 Oct 25. |
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| Abiraterone: Treatment B | Drug | Standardized meal administered 1 hour after the 1000 mg abiraterone acetate dose |
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| Abiraterone: Treatment C | Drug | Standardized meal administered 2 hours before the 1000 mg abiraterone acetate dose |
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| Abiraterone: Treatment D | Drug | Standardized meal administered 2 hours before and 2 hours after the 1000 mg abiraterone acetate dose |
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| Up to Day 4, treatment period 4 |
| Area under the plasma concentration-time curve from time 0 to time the last quantifiable concentration of abiraterone | Up to Day 4, treatment period 4 |
| Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone | Up to Day 4, treatment period 4 |
| Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone | Up to Day 4, treatment period 4 |
| First-order rate constant associated with the terminal portion of the curve of abiraterone | Up to Day 4, treatment period 4 |
| Time to last quantifiable plasma concentration of abiraterone | Up to Day 4, treatment period 4 |
| Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone | Up to Day 4, treatment period 4 |
| The number of participants affected by an adverse event | Up to the end of the study (4 days after final dose of study drug) or early withdrawal |